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Dibasic Calcium Phosphate Dihydrate Excipient | Uses, Suppliers, and Specifications

Dibasic Calcium Phosphate Dihydrate is an inorganic mineral compound and pharmaceutical excipient that contains Calcium ions (Ca2+) together with phosphate anions in a 1:1 molar ratio (chemical formula CaHPO4.2H2O). It is supplied as a white, odourless, tasteless powder or crystalline solid and occurs as triclinic crystals.

Synonyms and Trade Names: Dibasic Calcium Phosphate Hydrate; Calcium Hydrogen Phosphate; Calcium Hydrogen Phosphate Dihydrate; Calcium Hydrogen Orthophosphate dihydrate; Calcium Monohydrogen Phosphate Dihydrate; Di-Cafos; Dicalcium Orthophosphate; DI-TAB; E341; Emcompress

Pharmacopoeial Compliance: USP-NF; Ph.Eur; IP; J.P; FCC

Uses and Applications: Tablet and Capsule Diluent and Source of Calcium

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EMCOMPRESs® - JRS Pharma

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DI-CAFOS® D 160 - Budenheim KG

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Di-Tab® Dibasic Calcium Phosphate Dihydrate -Innophos Inc

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Description

Dibasic calcium phosphate dihydrate is an inorganic mineral and pharmaceutical excipient that is chemically composed of Calcium ions (Ca2+) and phosphate anions in a 1:1 molar ratio. It is also known as Calcium hydrogen phosphate dihydrate, Calcium hydrogen orthophosphate dihydrate, Calcium monohydrogen phosphate dihydrate, Dicalcium orthophosphate, DCP and DCPD.

Dibasic calcium phosphate belongs to a family of eleven mineral compounds that are collectively known as Calcium phosphate. They find important applications across the medical, geology, construction, and dentistry sectors. Depending on the methods of production, the materials obtained differ in function, composition, structure, physical properties and applications.

In the pharmaceutical field, the three most important minerals from this family are Dibasic calcium phosphate anhydrous, Dibasic calcium phosphate dihydrate, and Tricalcium phosphate, which are used as diluents and fillers in solid dosage development.

Dibasic calcium phosphate dihydrate has the empirical formula CaHPO4.2H2O, and therefore exists as the dihydrate. The “di” prefix in the common name arises because the formation of the HPO42– anion involves the removal of two protons from phosphoric acid, H3PO4.

Dibasic calcium phosphate dihydrate is a white, odourless, tasteless powder or crystalline solid, and occurs as monoclinic crystals.

Chemical Structure & Identifiers


Chemical Name Calcium hydrogen phosphate dihydrate
CAS Registry Number [7789-77-7]
Empirical Formula CaHPO4.2H2O
Molecular Weight 172.09
EC Number 231-826-1
UNII Code O7TSZ97GEP

Regulatory Status

Dibasic calcium phosphate dihydrate is an approved pharmaceutical excipient  and an authorised food additive in Europe. It is currently listed in the USP-NF, Ph.Eur and J.P. It is also GRAS listed and is included in the FDA Inactive Ingredients Database (covering oral capsules and tablets). Dibasic calcium phosphate dihydrate finds wide use in oral pharmaceutical products, food products, and toothpastes owing to its acceptability as a relatively nontoxic and non-irritant material.

Physicochemical Properties

Form Solid, powder
Appearance White powder or crystalline solid
pH (20% slurry) 7.4
Angle of repose   28.30
Bulk density 0.915 g/ml
Tapped density 1.17 g/ml
True density 2.389 gml
Flowability . 9 – 30 g/s (dependent on grade)
Melting point N/A

Dehydrates below 1000C

Moisture content Typically < 5%. Dibasic turn phosphate dihvdrate contains two molecules of water of crystallization, which can he lost at temperatures well below 1000C,
Particle size distribution Varies depending on grade. Coarse grades typically 200 µm while fine grades are ~ 10 µm.
Solubility Practically insoluble in ethanol, ether, and water; soluble in dilute acids.
Specific surface area 0.44 – 0.46 m2/g

Pharmacopeoeal Specifications

  USP-NF Ph.Eur J.P
Official name Dibasic Calcium Phosphate Dihydrate Calcium Hydrogen Phosphate Dihydrate Dibasic Calcium Phosphate Hydrate
Authorised use Excipient

Active

Excipient

Active

Excipient

Active

Definition specified specified specified
Identification specified specified specified
Characters n/a specified specified
Loss on ignition 24.5 -26.5% 24.5 -26.5% n/a
Loss of drying n/a n/a 19.5 -22.0%
Acid-insoluble substances ≤ 0.2% ≤ 0.2% ≤ 0.05%
Heavy metals ≤ 0.003% ≤ 40 ppm ≤ 31 ppm
Chloride ≤ 0.25% ≤ 0.25% ≤ 0.248%
Fluoride ≤ 0.005% ≤ 100 ppm
Sulfate ≤ 0.5% ≤ 0.5% ≤ 0.160%
Carbonate specified specified specified
Barium specified specified specified
Arsenic ≤ 3µg/g ≤ 10 ppm ≤ 2 ppm
Iron n/a ≤ 400 ppm n/a
Assay 98.0 -105.0% 98.0 -105.0% ≥ 98.0%
Labelling specified n/a n/a

Key: n/a Specification is not listed

*All claims with respect to conformity are subject to our Terms and Conditions. No express or implied warranty is made for specific properties or fitness for any particular application or purpose.

Applications in Pharmaceutical Formulations or Technology

Dibasic calcium phosphate dihydrate is primarily used as a tablet filler and diluent. It is also used as a source of calcium and phosphorus in nutritional supplements. It is one of the more widely used excipients, not only in pharmaceutical products but also in nutraceuticals and also in toothpastes owing to its abrasiveness.

In the pharmaceutical formulations, Dibasic calcium phosphate dehydrate is selected because of its excellent compactability and flow properties. The predominant deformation mechanism of coarse-grades is brittle fracture which significantly reduces strain-rate sensitivity and the tendency for tablets to laminate. This is highly advantageous during formulation scale-up in new product development which is less arduous. The only downside is that dibasic calcium phosphate dihydrate is abrasive, which severely reduces tooling life. Thereofore, high levels of lubricants are required in formulations (usually higher than 1% w/w for Magnesium stearate or Sodium stearyl fumarate).

Commercial grades of Dibasic calcium phosphate dihydrate are available in the form of a milled grade typically reserved for use in wet-granulation or roller-compaction, and a coarse grade meant for direct-compression applications.

Dibasic calcium phosphate dihydrate does not absorb moisture from the environment and remains stable at ambient conditions. However, if the material is subjected to particular conditions (high temperature and humidity), it can lose its water of crystallization. This phenomenon can have implications for high-temperature processes (packaging and aqueous film coating) or most moisture-sensitive actives.

Safety and Precautions

Dibasic calcium phosphate dihydrate is widely used in oral pharmaceutical products, food products, and toothpastes owing to its acceptability as a relatively nontoxic and non-irritant material.

Stability and Storage Conditions

Dibasic calcium phosphate dihydrate is a nonhygroscopic, relatively stable material. However, when incorrectly stored or processed, it can lose its water of crystallization, which can impact the stability of the excipient and subsequent processing of dosage forms. Therefore, the bulk material should be correctly stored (in a well-closed container in a cool, dry place away from direct heat or moisture).

When handling Dibasic calcium phosphate dihydrate, workers should observe required precautions appropriate to the circumstances and quantity of material being processed. As the milled grades can generate dust, the use of a respirator or dust mask is recommended.

Sustainability and Environmental Impact

Dibasic calcium phosphate is a naturally-occurring mineral although it may be obtained obtained synthetically using widely available non-critical resources. Being inert and non-toxic, it is considered safe for the environment, with minimal long-term impact on ecology or marine life. Dibasic calcium phosphate achieved a total score of 78/100 by the Excipients Forum Sustainable™ Chemistry.

Manufacturers & Suppliers

JRS Pharma

  • EMCOMPRESs®
  • EMCOMPRESs® Premium
  • EMCOMPRESs®  Premium Powder

BudenheimKG

  • DI-CAFOS® D 14
  • DI-CAFOS® D 160

Innophos Inc.

  • Di-Tab® Dibasic Calcium Phosphate Dihydrate – Granular

Additional Resources (Downloads)

References and Literature Used

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